Cgxp Administrator - Epping, South Africa - Aspen Pharma Group

Aspen Pharma Group
Aspen Pharma Group
Verified Company
Epping, South Africa

2 weeks ago

Thabo Mthembu

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Thabo Mthembu

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Description

BASIC JOB FUNCTIONS (Brief Summary):


  • Manage, maintain & improve regulatory compliance for computerized systems.
  • Coordination of support activities relating to validation
  • Knowledge of regulations governing pharmaceutical manufacturing (API)
  • Maintaining maintenance contracts and managing software renewals
  • Collation of GxP reports /statistics
  • Testing of data restore capability (Business continuity)
  • Liaising with enduser w.r.t enduser requirements (Capex and departmental requirements)
  • Basic active directory management across various networks
  • Inventory /Asset management
  • Change control management
- cGxP documentation pertaining to various systems

  • Adherence to system review procedures
  • Software/Hardware Repairs
  • Monitor and maintain system upgrade /patch management
  • Install and configure new computers and other IT equipment related to the laboratory
  • Repair and upgrade the different types of systems (software and hardware)
  • Printer, scanner, and copier repairs
  • Manage users' groups
  • Liaise and manage vendor callouts /call logging
  • Ad hoc ITrelated requests
  • Assist staff with ITrelated issues when called upon
  • Carry out other duties as may be requested by management
  • Standby where required

PERSONAL ATTRIBUTES (Brief Summary):


  • Must be organized handson, disciplined, punctual, honest, and have sober habits
  • Effective communication with staff at all levels of the business
  • Have an eye for detail and accuracy
  • Requires an infallible ability to work well under pressure
  • Strong customer service orientation
  • Ability to translate IT terminology into the userfriendly terminology

JOB REQUIREMENTS:


  • Minimum Grade 12 or equivalent as per NQF framework
  • A+ or N+ certification or 13 years in a similar role
  • Experience with Laboratory systems & 21 CFR part 11 (Chromatography etc.)
  • Good communication skills telephonically/written
  • SAP administration (added advantage)
  • Auditing: Added advantage
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